MedPath

Vitamin D3

Generic Name
Vitamin D3
Brand Names
Adrovance, Animi-3 With Vitamin D, Citranatal B-calm Kit, Citranatal Harmony, Fosamax Plus D, Fosavance, Infuvite, Infuvite Pediatric, Mvc-fluoride, Natafort, Pregvit, Vidextra, Vantavo (previously Alendronate sodium and colecalciferol, MSD)
Drug Type
Small Molecule
Chemical Formula
C27H44O
CAS Number
67-97-0
Unique Ingredient Identifier
1C6V77QF41

Overview

Vitamin D, in general, is a secosteroid generated in the skin when 7-dehydrocholesterol located there interacts with ultraviolet irradiation - like that commonly found in sunlight . Both the endogenous form of vitamin D (that results from 7-dehydrocholesterol transformation), vitamin D3 (cholecalciferol), and the plant-derived form, vitamin D2 (ergocalciferol), are considered the main forms of vitamin d and are found in various types of food for daily intake . Structurally, ergocalciferol differs from cholecalciferol in that it possesses a double bond between C22 and C23 and has an additional methyl group at C24 . Finally, ergocalciferol is pharmacologically less potent than cholecalciferol, which makes vitamin D3 the preferred agent for medical use . Appropriate levels of vitamin D must be upheld in the body in order to maintain calcium and phosphorus levels in a healthy physiologic range to sustain a variety of metabolic functions, transcription regulation, and bone metabolism . However, studies are also ongoing to determine whether or not cholecalciferol may also play certain roles in cancer, autoimmune disorders, cardiovascular disease, and other medical conditions that may be associated with vitamin D deficiency .

Background

Vitamin D, in general, is a secosteroid generated in the skin when 7-dehydrocholesterol located there interacts with ultraviolet irradiation - like that commonly found in sunlight . Both the endogenous form of vitamin D (that results from 7-dehydrocholesterol transformation), vitamin D3 (cholecalciferol), and the plant-derived form, vitamin D2 (ergocalciferol), are considered the main forms of vitamin d and are found in various types of food for daily intake . Structurally, ergocalciferol differs from cholecalciferol in that it possesses a double bond between C22 and C23 and has an additional methyl group at C24 . Finally, ergocalciferol is pharmacologically less potent than cholecalciferol, which makes vitamin D3 the preferred agent for medical use . Appropriate levels of vitamin D must be upheld in the body in order to maintain calcium and phosphorus levels in a healthy physiologic range to sustain a variety of metabolic functions, transcription regulation, and bone metabolism . However, studies are also ongoing to determine whether or not cholecalciferol may also play certain roles in cancer, autoimmune disorders, cardiovascular disease, and other medical conditions that may be associated with vitamin D deficiency .

Indication

Cholecalciferol use is indicated for the treatment of specific medical conditions like refractory rickets (or vitamin D resistant rickets), hypoparathyroidism, and familial hypophosphatemia . Concurrently, as one of the most commonly utilized forms of vitamin D, cholecalciferol is also very frequently used as a supplement in individuals to maintain sufficient vitamin d levels in the body or to treat vitamin D deficiency, as well as various medical conditions that can be associated directly or indirectly with vitamin d insufficiency like osteoporosis and chronic kidney disease, among others .

Associated Conditions

  • Bone Fractures
  • Calcium and Vitamin D Deficiencies
  • Deficiency of Vitamin D3
  • Deficiency, Vitamin A
  • Deficiency, Vitamin D
  • Hip Fracture
  • Hypoparathyroidism
  • Hypophosphatemia, Familial
  • Menopause
  • Osteomalacia
  • Osteoporosis
  • Postmenopausal Osteoporosis
  • Vertebral Fractures
  • Vitamin D Resistant Rickets
  • Vitamin Deficiency
  • Severe Bone Resorption
  • Spine fracture

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2020/07/27
N/A
UNKNOWN
2020/07/20
Phase 3
Completed
2020/07/13
Phase 3
Completed
2020/06/23
Not Applicable
Completed
2020/06/19
Not Applicable
Completed
Baqiyatallah Medical Sciences University
2020/06/02
Phase 4
Completed
Vitamin D Study Group
2020/06/02
Phase 2
Completed
Heba Omara
2020/05/26
Not Applicable
Completed
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
2020/05/22
Not Applicable
Completed
2020/05/06
Phase 4
Completed
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
PureTek Corporation
59088-162
ORAL
18.75 ug in 1 1
4/1/2024
Avion Pharmaceuticals, LLC
75854-315
ORAL
1000 [iU] in 1 1
1/7/2021
BonGeo Pharmaceuticals, Inc.
52796-177
ORAL
600 [iU] in 1 1
2/1/2024
PureTek Corporation
59088-108
ORAL
10 ug in 1 1
9/2/2022
Bryant Ranch Prepack
63629-1136
ORAL
400 [iU] in 1 1
12/30/2021
Mission Pharmacal Company
0178-0896
ORAL
200 [iU] in 1 1
1/8/2024
Acella Pharmaceuticals, LLC
42192-323
ORAL
400 [iU] in 1 1
9/11/2018
PureTek Corporation
59088-163
ORAL
125 ug in 1 1
1/11/2023
PureTek Corporation
59088-173
ORAL
20 ug in 1 1
1/11/2023
PureTek Corporation
59088-176
ORAL
20 ug in 1 1
1/11/2023

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Company
Licence No.
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Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
Prenatal Plus
396774
Medicine
A
9/30/2022
Eagle Clinical Tresos B Professional +
489429
Medicine
A
5/21/2025
VitalBoost
485229
Medicine
A
4/4/2025
Preconception Multi for Women
476988
Medicine
A
1/29/2025
Witsbb Vitamin A D softgel for Kids (clear)
475060
Medicine
A
1/6/2025
Nature’s Way Kids Smart Vita Gummies High Strength Calcium Vitamin K2+D3
473415
Pharmacare Laboratories Pty Ltd
Medicine
A
12/17/2024
Multi Vitamin
472186
Medicine
A
12/9/2024
Kidtal®️ Liquid Calcium
468809
Medicine
A
11/15/2024
Men`s Multi
467971
Medicine
A
11/11/2024
Skin + Gut
464909
Medicine
A
10/18/2024
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